Guidance Documents

Question and answer concerning moving controlled substances to another address without changing the address of the DEA registered location.

Question and answer concerning reporting of theft and/or loss of controlled substances during civil unrest and looting.

The guidance discusses the meaning of the term “agent of a foreign principal” as used in FARA.

During the Covid19 Public Health Emergency, DEA will temporarily permit registered practitioners such as hospitals, pharmacies, and physicians to distribute controlled substances (CS) in excess of five percent of their total number of dosage units of CS distributed to other registered dispensers during this calendar year, without registering as a distributor.  All DEA security, recordkeeping and other applicable regulations, including state requirements, remain in effect.

Due to the Covid-19 Public Health Emergency, DEA-registered hospital/clinics may utilize alternate satellite hospital/clinic locations providing temporary services under their current registrations. DEA will allow such satellite hospitals/clinics to handle controlled substances and to receive shipments of controlled substances directly from distributors.  DEA must be notified by all registered hospital/clinics of any satellite locations intending to handle controlled substances.

Due to the Covid-19 Public Health Emergency, DEA has issued guidance to Distributors to ensure regulatory compliance regarding secure delivery of controlled substance shipments to hospitals, pharmacies and NTPs, documentation and recordkeeping, due diligence requirements, and authorization for emergency alternate distribution sites.

During the COVID-19 public health emergency, DEA-registered hospitals/clinics may conduct remote identity proofing of individual practitioners to issue authentication credentials to eligible practitioners engaged in electronic prescribing of controlled substances, in conformance with existing regulations. DEA suggests using a device that allows for real-time, two-way, audio-visual interactive communication to do so.

In response to the COVID19 public health emergency(PHE) declared by HHS, the DEA has adopted policies to allow DEA reg. practitioners to prescribe controlled substances(CS) without having to interact in-person with their patients. This chart only addresses prescribing CS and doesn’t address administering or direct dispensing of CS, including by OTPs or hospitals. These go into effect 3-31-20, and will remain in effect for the duration of the PHE, unless DEA specifies an earlier date.

On March 26, 2020, due to the HHS declared health crises, DEA has granted an exception to 21 CFR 1305.13 regarding the requirement that a purchaser mail a hard copy version of DEA Form 222 to the original supplier in order to ensure an adequate supply of controlled substances for the duration of this public health emergency.

Due to the COVID-19 public health emergency declared by HHS on 1-31-20, the DEA is granting an exception to the requirement that a practitioner be registered in each state where they dispense controlled substances. However, under this temporary exception, practitioners may dispense controlled in states where they do not hold a registration, provided that they still hold at least one registration, and comply with all applicable state laws.

On March 21, 2020, the Drug Enforcement Administration issued guidance concerning the refill of schedule II through V controlled substances during the COVID-19 national health emergency.

DEA reviewed the request for an exception to 21 CFR 1301.74(i), and took into account the safeguards against diversion incorporated into the guidance for Opioid Treatment Programs, and granted the exception to 21 CFR 11301.74(i), but only to the extent that such activities will take place during the HHS-declared public health emergency.